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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia

Phase 3

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have ≥ 1 of the following high-risk prognostic factors: Presence of 17p del by central laboratory, Presence of 11q del by central laboratory, Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment, Must have received ≥ 1 prior therapies for CLL

ECOG performance status of 0 to 2

Must not have

Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer

Known CNS lymphoma or leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (days -28 to -1) through 83.7 months (maximum observed duration)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new cancer drug against an existing one to see how well each extends the lives of patients with a specific kind of leukemia.

Who is the study for?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) who have high-risk factors like certain genetic deletions or active disease requiring treatment. They must have had at least one prior CLL therapy, meet specific blood cell count criteria, and not be dependent on blood transfusions. People with a history of CNS leukemia, recent major surgery, or exposure to similar drugs are excluded.

What is being tested?

The study compares the effectiveness of two drugs in treating CLL: Acalabrutinib and Ibrutinib. It focuses on which drug better prevents the disease from getting worse in patients who've already been treated before.

What are the potential side effects?

Potential side effects for both Acalabrutinib and Ibrutinib include diarrhea, bleeding problems, high blood pressure, irregular heartbeat, muscle and bone pain, fatigue, rash as well as increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high-risk CLL with specific genetic changes or need treatment based on certain criteria.

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I can care for myself and am up and about more than 50% of my waking hours.

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I have been diagnosed with chronic lymphocytic leukemia (CLL).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need treatment with a strong medication that affects liver enzymes.

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I have been diagnosed with CNS lymphoma or leukemia.

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I have uncontrolled autoimmune blood disorders.

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I have not had prior therapy with radio- or toxin-conjugated antibodies.

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I have or am suspected to have Richter's syndrome or prolymphocytic leukemia.

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I have a history of unusual bleeding.

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I have been diagnosed with HIV.

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I have previously been treated with ibrutinib or drugs targeting B-cells.

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I have had a stem cell transplant before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (days -28 to -1) through 83.7 months (maximum observed duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (days -28 to -1) through 83.7 months (maximum observed duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (days -28 to -1) through 83.7 months (maximum observed duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment

Secondary study objectives

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline

Number of Participants With Shift From Baseline to Worst (Grade 3 and 4) Postbaseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

+7 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AcalabrutinibExperimental Treatment1 Intervention

Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.

Group II: IbrutinibActive Control1 Intervention

Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

0 / 12Eligibility criteria met